Section 109(4)(a) in The Drugs and Cosmetics Rules, 1945
(a)in cases where a test for potency or toxicity is required, by these rules or not being so required, is accepted by the licensing authority as sufficient for the purpose of fixing the date of completion of manufacture, the date on which the substance was removed from cold storage after having been kept at a temperature not exceeding 5oC continuously for a period not exceeding two years from the time when the last test was completed;